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Written by: Zheng Cuibi Zhu Haiqi
2021-02-19 00:13
Last update date: 2021-02-19 00:14
The Food and Health Bureau approved the emergency use application of Kexing Vaccine on Thursday (18th) and uploaded a report written by experts explaining the reasons.
Kexing admits that in the third phase of the clinical test study, the proportion of people over 60 years old is low. Therefore, the protective effect of the vaccine on this group of people is "not sufficient." Risks determine the necessity of vaccination.”
Some pharmacists believe that the elderly who are convenient and have few chronic diseases can be vaccinated with Kexing vaccine, while the elderly who are bedridden for a long time may not be suitable for injection.
It is understood that the two scientific committees under the Department of Health will meet on Friday (19th) to discuss groups suitable for vaccination. The focus will then be on whether the elderly recommend vaccination.
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In the document, Kexing mentioned that in the third phase of the test, the proportion of people over the age of 60 was low, only 5.1%. Therefore, the vaccine has "inadequate evidence of protective efficacy" for this group of people. When it is recommended to arrange vaccination, The necessity of vaccination should be determined based on the health status and exposure risk of the vaccinators.
In the first and second phase tests, it was shown that people over 60 years of age will produce a certain degree of neutralizing antibodies after vaccination.
For example, the 72 people who participated in the first phase of the test had an antibody production rate ranging from 95.7% to 100%; the 350 people in the second phase had an antibody rate ranging from 90.7% to 99%.
Pregnant women, chronic patients, and people with allergies should not get injections
In addition, the document also mentioned that this vaccine is contraindicated for five types of people, including pregnant and lactating women, patients with uncontrolled severe chronic diseases, patients with severe neurological diseases, severe allergic reactions to the vaccine, and Those who are allergic to vaccine ingredients.
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Kexing has lower side effects, suitable for frail elderly
The side effects of Kexing vaccine are relatively low, among which the fever rate is only 0.15%. Earlier, experts pointed out that vaccines with low side effects are less protective, but they are also suitable for frail elderly people.
However, Cui Junming, president of the Hong Kong Institute of Hospital Pharmacists, believes that elderly people with convenient mobility and few chronic illnesses can be vaccinated with Kexing vaccine, but the elderly who are bedridden for a long time may not be suitable for injection because they are worried about the consequences if these elderly people develop a fever. It will be more serious, and the bedridden elders themselves will not move around in the community. The source of infection is mostly family members and staff of the institution. As long as the people who come into contact with them are vaccinated, the virus can be reduced.
Cui Junming also explained that the side effects caused by the vaccine include systemic and local side effects. The former includes fever and headache, while the latter is pain at the injection site. Systemic side effects are of more concern because they affect systemic functions, especially fever. Don’t know if it will affect the late-stage long-term patients. It is like diabetic patients, because fever will affect the metabolism, respiratory system and even the liver. If the elderly are weak and chronic diseases are not controlled, the fever will be a burden.” He added that the first two phases of clinical studies are mainly about To explore the time between two injections, the side effect ratio needs to be reflected in the third phase of the study.
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In Norway, very frail elderly people died after being vaccinated with the BioNTech vaccine. The "Scientific Committee on Vaccine Preventable Diseases" and the "Scientific Committee on New Discoveries and Zoological Infectious Diseases" under the Center for Health Protection of the Department of Health believe that there is no evidence to show that The mortality rate of the frail elderly after being vaccinated with this vaccine has exceeded expectations and has increased abnormally. There is no clear evidence that the deaths are due to the use of this vaccine. However, it is pointed out that the severely frail elderly (such as elderly Long-term bedridden elders in hospitals), especially the elderly (such as those over 85 years old), the benefits and risks of vaccination should be assessed by the attending doctor individually, and relevant clinical judgments should also be made cautiously .
It is understood that the above two committees met on Friday to decide which group of people are suitable for vaccinating Kexing vaccine.
Kexing admitted that in the third phase of the test, the proportion of people over 60 years old is low, so the evidence of the vaccine's protective effect on this group of people is insufficient.
(Provided by Kexing)
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